Anemia Clinical Trial
Official title:
Impact Evaluation of Intermittent Preventive Treatment of Malaria in Infants Plus (IPTi+) in Cameroon: The Plus Project
NCT number | NCT05889052 |
Other study ID # | PLUS-27988-CAM |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 19, 2023 |
Est. completion date | July 2025 |
The Plus Project will assess the impact, operational feasibility, efficacy, effectiveness, and cost-effectiveness of PMC. Specifically, the impact evaluation will involve monitoring a passive cohort of all children in the study area reporting all doses of SP received and the number of confirmed cases of malaria and anaemia, as well as a prospective active cohort of children who will have seven home visits over an 18-month period. The total number of participants is expected to be approximately 2,080 children in the areas served by 35 health centres in Cameroon. The results of this study will allow direct evaluation of the protective efficacy of PMC on malaria incidence, severe anaemia, and malaria mortality.
Status | Recruiting |
Enrollment | 2080 |
Est. completion date | July 2025 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 9 Months |
Eligibility | Inclusion Criteria: - Reside in Soa (intervention) or Mbankomo (control) health districts. - Agree to take part in the census. - Aged 6-9 months at the time of enrolment. Exclusion Criteria: - Parent/caregiver refused to participate in the cohort. - Parent/caregiver did not give informed consent. |
Country | Name | City | State |
---|---|---|---|
Cameroon | Multiple | Soa/Mbankomo |
Lead Sponsor | Collaborator |
---|---|
London School of Hygiene and Tropical Medicine | Fobang Institutes Centre for Health Implementation and Translational Research |
Cameroon,
WHO Malaria Report 2022, World Health Organisation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of malaria infection and clinical malaria | Incidence of: (1) malaria infection, and (2) clinical malaria in children residing in areas designated to receive PMC (intervention) versus standard care (control). | 18 months | |
Secondary | Incidence of severe malaria, malaria deaths, anaemia and severe anaemia | Incidence of: (1) severe malaria, (2) malaria deaths, (3) anaemia, and (4) severe anaemia in children residing in areas designated to receive PMC (intervention) versus standard care (control). | 18 months | |
Secondary | Malaria and anaemia incidence by delivery platform, number of doses and dose schedule | Measure differences in incidence between children residing in areas designated to receive PMC (intervention) versus standard of care (control) based on differences in SP dose patterns by delivery platform, number of doses of SP, and the SP dose schedule. | 18 months | |
Secondary | Dose-response effects of SP on malaria and anaemia | Measure the dose-response effects of SP on incidence of: (1) malaria infection, (2) clinical malaria, (3) severe malaria, (4) anaemia, (5) severe anaemia, and (6) malaria mortality throughout the period of observation. | 18 months | |
Secondary | Effects of distance to health facility on malaria and anaemia | Measure the effects of distance to health facility on incidence of: (1) malaria infection, (2) clinical malaria, (3) severe malaria, (4) anaemia, (5) severe anaemia, and (6) malaria mortality throughout the period of observation. | 18 months | |
Secondary | Incidence of moderate, severe and overall malnutrition | Incidence of: (1) moderate, (2) severe, and (3) overall malnutrition among children residing in areas designated to receive PMC (intervention) versus standard care (control). | 12 months |
Status | Clinical Trial | Phase | |
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